The following data is part of a premarket notification filed by Hml Inc/biotechnology Transfer with the FDA for Micro Organism Growth Sys-m1000.
| Device ID | K843000 |
| 510k Number | K843000 |
| Device Name: | MICRO ORGANISM GROWTH SYS-M1000 |
| Classification | Device, Specimen Collection |
| Applicant | HML INC/BIOTECHNOLOGY TRANSFER 950 KINGS HIGHWAY NORTH Cherry Hill , NJ 08034 - |
| Contact | Julius J Jablonsky |
| Correspondent | Julius J Jablonsky HML INC/BIOTECHNOLOGY TRANSFER 950 KINGS HIGHWAY NORTH Cherry Hill , NJ 08034 - |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1985-02-06 |